How Prepared Is Your Operations Organization?

A reality check for Pharma Leaders

 As regulators push to keep pace with—if not get ahead of—market and industry developments, pharma leaders should be looking critically within their organizations to assess their preparedness. They should ask themselves these key questions:

• How closely are we working with regulators to help shape global quality standards for the future?
• As an organization, how do we think about quality today? Are we using the right metrics to approach quality proactively in our design and manufacturing processes? Do our company’s incentives emphasize profits over quality? (For example, is it worse to miss profit goals than quality goals?) Does our culture encourage quality?
• Are quality reviews and standards in our emerging markets plants keeping abreast with emerging trends? Are we proactively assessing the risks to our products from adulteration, counterfeiting, theft, and intentional contamination and taking all the necessary precautions to prevent those?
•  Are we fully aware of the compliance and quality concerns within our organization? How, for example, have we adapted our production practices and associated compliance activities as the supply chain (both inputs and outputs) has grown more globalized?
• How ironclad is our supplier qualification process? What methods do we use to assess risk among our suppliers?
•  Where are the gaps in our internal monitoring processes? What tools and technologies can we adapt to improve our surveillance?
•  Can we improve our preparations for regulatory surveillance activities, for example, by leveraging third parties to conduct mock inspections? What specifically do we know about inspection changes? Do we understand the kinds of questions inspectors will ask, and the type of data we will need to have readily available?

(Abstract from the source: “Evolving beyond global regulators: An operational lens” by Ted Fuhr, Nasser Khan, Navjot Singh │ Published source: ‘Operations for the Executive Suite: Opening new horizons for current and future pharma leaders’ │ A Book by McKinsey & Company │ 2012)